Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: C21: IMP will be administered twice daily orally for 14 days from Visit 2 to Visit 15 as follows: 1. Morning dose: Two 50 mg capsules to be taken with a glass of water after minimum 2 h
Sponsors
Vicore Pharma AB
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age �18 years or the legal age of consent in the jurisdiction in which the trial is taking place at the time of signing the informed consent. (Specific for India; Age �18 at the time of signing the informed consent to �65 years.) 2. Hospitalized due to SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) test, documented by either of the following: a. PCR positive in sample collected b. PCR positive in sample collected �72 hours and �7 days prior to randomization, documented inability to obtain a repeat sample AND progressive disease suggestive of ongoing SARS-CoV-2 infection. 3. A score of 5 or 6 on the 8-point ordinal scale: a. Score 5: Hospitalized, requiring supplemental oxygen. b. Score 6: Hospitalized, on non-invasive ventilation or high-flow oxygen device. 4. Contraceptive use by men and women of childbearing potential consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 5. Written informed consent, consistent with International Council for Harmonization (ICH Good Clinical Practice (GCP) R2 and local laws, obtained before the initiation of any trial-related procedure. 6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 7. Specific for India: For subjects with an ordinal scale score of 5, moderate to severe COVID-19 disease confirmed by at an SpO2 � 93 % or a respiratory rate � 24/min on room air. Note: If a subject is on supplemental oxygen with SpO2 >93% and respiratory rate <24/min, but desaturation to � 93 % or increase of respiratory rate to � 24/min on lower supplemental oxygen or room air is documented during screening, the inclusion criterion is considered to be met.
Exclusion criteria
Exclusion criteria: 1. Concurrent serious medical condition which in the opinion of the investigator constitutes a risk or a contraindication for the participation in the trial or that could interfere with the trial objectives, conduct or evaluation. 2. Known, active tuberculosis, active hepatitis B, C, or human immunodeficiency virus (HIV) infection (i.e., HIV with a CD4 count 3. Impaired hepatic function (i.e., Child-Pugh class B or C). 4. Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR) �30 ml/min/1.73 m2). 5. COVID-19 symptom onset >14 days prior to screening (Visit 1). 6. Hospitalized due to COVID-19 for >72 hours at screening (Visit 1). 7. Invasive mechanical ventilation or ECMO within 72 hours of screening (Visit 1) 8. Expected need for invasive mechanical ventilation or ECMO in 9. Moderate to severe ARDS (e.g., same-day PaO2/FiO2 �200 mmHg; or SpO2/FiO2 �232 if arterial blood gas test is not available), if on non-invasive mechanical ventilation or high-flow oxygen. 10. Pregnant or breast-feeding female subjects. 11. Any previous and concurrent experimental treatment for COVID-19 that is not considered local SoC. 12. Treatment with the medications listed below within 1 week prior to screening (Visit 1) or anticipated need for such medication during the participation in this trial: a. Strong Cytochrome P450 (CYP) 3A4 inducers. b. P-glycoprotein (P-gp) substrates with narrow therapeutic index. c. High dose BCRP sensitive substrates. d. Warfarin. e. Sulphasalazine or rosuvastatin. 13. Current or previous participation in any other clinical trial where the subject has received a dose of IMP within 1 month or 5 half-lives of the IMP, whichever is longest, prior to screening (Visit 1). 14. Positive pregnancy test 15. Abnormal laboratory value at screening (Visit 1) indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects discharged from hospital and free of supplemental oxygen at Day 15.Timepoint: Proportion of subjects discharged from hospital and free of supplemental oxygen at Day 15. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AE)sTimepoint: During study participation;All-cause mortality up to Day 60Timepoint: Will be assessed upto days 60;All-cause mortality up to Days 8, 15, 22 and 29Timepoint: Will be assessed upto days 29;Change from baseline in CRP at Day 15Timepoint: Will be assessed on days 15;Change from baseline in lactate dehydrogenase (LDH) at Day 15Timepoint: Will be assessed on days 15;Change from baseline in peripheral capillary oxygen saturation (SpO2) / fraction of inspired oxygen (FiO2) at Day 15Timepoint: Will be assessed on days 15;Changes in safety laboratory assessmentsTimepoint: During study participation;Duration of hospitalization, including re-hospitalization, up to Day 60Timepoint: Will be assessed upto days 60;Duration of intensive care unit stay, including re-admission, up to Day 60.Timepoint: Will be assessed upto days 60;PK profile of C21 in subjects with COVID-19Timepoint: Will be assessed on visit 2;Proportion of hospitalized subjects on non-invasive, invasive mechanical ventilation, extra corporeal membrane oxygenation (ECMO) or supplemental oxygen use at Days 8, 15, 22, 29 and 60.Timepoint: Will be assessed on days 8, 15, 22, 29 & 60;Proportion of subjects discharged from hospital and free of supplemental oxygen at Days 8, 22 and 29.Timepoint: Will be assessed on days 8, 22 & 29;Proportion of subjects free of respiratory failure at Days 8, 22, 29 and 60, and respiratory failure free days up to Day 60.Timepoint: Will be assessed upto days 60;Proportion of subjects free of respiratory failure, defined as an 8-point ordinal scale score more than 6, at Day 15.Timepoint: Will be assessed on days 15;Proportion of subjects in each category of the 8-point ordinal scale at Days 8, 15, 22, 29 and 60Timepoint: Will be assessed on days 8, 15, 22, 29 & 60;Proportion of subjects needing intensive care unit stay at Days 8, 15, 22, 29 and 60Timepoint: Will be assessed on days 8, 15, 22, 29 & 60;Proportion of subjects on invasive mechanical ventilation or | — |
Countries
Argentina, Brazil, Colombia, Czech Republic, India, Peru, Philippines, Poland, Russian Federation, Ukraine, United States of America
Contacts
Public ContactMr Gajendrasinh Chanchu
Orphan Reach
Outcome results
None listed